TABLE 3.

Differences in LS mean changes from baseline in MOS-Sleep parameters between TX-001HR and placebo in MITT population

MOS-Sleep parameters	Estradiol/Progesterone
	1 mg/100 mg	0.5 mg/100 mg	0.5 mg/50 mg	0.25 mg/50 mg
Total
Week 12	−4.88 ± 1.6b	−3.61 ± 1.6a	−3.44 ± 1.6a	−2.53 ± 1.6
Month 6	−5.39 ± 1.7b	−5.39 ± 1.7b	−4.88 ± 1.7b	−4.42 ± 1.7b
Month 12	−6.54 ± 1.9c	−7.61 ± 1.8c	−7.44 ± 1.8c	−6.76 ± 1.9c
Sleep Problems Index I
Week 12	−4.92 ± 1.7b	−3.79 ± 1.7a	−3.28 ± 1.6a	−3.41 ± 1.7a
Month 6	−5.69 ± 1.7c	−5.58 ± 1.7c	−5.12 ± 1.7b	−5.11 ± 1.7b
Month 12	−6.01 ± 1.9c	−7.22 ± 1.9c	−6.92 ± 1.9c	−6.42 ± 1.9c
Sleep Problems Index II
Week 12	−4.60 ± 1.6b	−3.49 ± 1.6a	−3.15 ± 1.6a	−2.48 ± 1.6
Month 6	−5.44 ± 1.7c	−5.53 ± 1.7c	−5.12 ± 1.7b	−4.64 ± 1.7b
Month 12	−6.28 ± 1.8c	−7.58 ± 1.8c	−7.43 ± 1.8c	−6.54 ± 1.9c
Sleep Disturbance
Week 12	−7.34 ± 2.1c	−5.60 ± 2.1b	−5.13 ± 2.1a	−3.04 ± 2.1
Month 6	−8.38 ± 2.2c	−7.52 ± 2.2c	−7.32 ± 2.2c	−5.60 ± 2.2a
Month 12	−8.97 ± 2.4c	−9.60 ± 2.4c	−9.30 ± 2.4c	−7.72 ± 2.4b
Sleep Somnolence
Week 12	−1.64 ± 1.7	−1.18 ± 1.7	0.14 ± 1.7	−0.68 ± 1.7
Month 6	−1.09 ± 1.9	−1.14 ± 1.9	−1.42 ± 1.9	−0.12 ± 1.9
Month 12	−3.36 ± 2.0	−5.34 ± 2.0b	−4.94 ± 2.0a	−3.88 ± 2.0
Sleep Adequacy
Week 12	4.35 ± 2.5	2.61 ± 2.5	3.72 ± 2.5	3.48 ± 2.5
Month 6	5.11 ± 2.6	7.10 ± 2.6b	5.90 ± 2.6a	8.38 ± 2.6b
Month 12	5.02 ± 2.9	7.56 ± 2.9b	7.65 ± 2.9b	7.89 ± 2.9b
Snoring
Week 12	2.02 ± 2.6	1.97 ± 2.6	1.50 ± 2.6	1.59 ± 2.6
Month 6	0.25 ± 2.7	−1.65 ± 2.7	−3.68 ± 2.7	−1.17 ± 2.7
Month 12	1.25 ± 2.9	−1.35 ± 2.8	−0.44 ± 2.8	−0.39 ± 2.9
Sleep Shortness of Breath or Headache
Week 12	−0.44 ± 2.1	−0.64 ± 2.1	0.51 ± 2.0	−−0.46 ± 2.0
Month 6	−2.46 ± 2.2	−2.27 ± 2.1	−1.44 ± 2.1	−1.47 ± 2.2
Month 12	−1.96 ± 2.3	−2.43 ± 2.3	−1.51 ± 2.3	−1.68 ± 2.3

Data expressed as LS Mean ± SE.

LS, least square; MITT, modified intent-to-treat; SE, standard error.

^aP < 0.05.

^bP ≤ 0.01.

^cP ≤ 0.001 vs placebo.